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Generic Biologics

Posted by: Ken Phelps

Published on: February 28, 2009

This past week I attended the 2009 Generic Pharmaceutical Association annual meeting. Much time was devoted to the issue of generic versions of biologics. Adding to the debate was the what to call these drugs. The GPhA prefers to call them biosimilars (nice ring to sameness) or biogenerics and BIO prefers to call them follow-on biologics (fobs?).

The meeting featured a debate between GPhA President and CEO Kathleen Jaeger and BIO President and CEO Jim Greenwood and an attorney for each organization. Lively debate ensued. Though both parties agreed that legislation is inevitable, both disagreed on some key details. The most significant detail, I think all would agree on, is the need for and length of market exclusivity (or, as BIO states, data exclusivity). I have remarked before about the concepts of patent and market exclusivity – for small molecules the 1984 Hatch-Waxman Amendment calls for 3-, 5- or 7 year market exclusivity for clinical, new entity or orphan respectively. BIO wants 14 years for newly approved biologicals (they originally wanted 17 years, but now it is 14). GPhA says the Hatch-Waxman periods have been good for 25 years and should be good enough for the future.

Given that Henry Waxman is now chairman of the House committee with oversight on this legislation, BIO has its work cut out for their lobbyists.

Mention was made of “biobetters”. CEO’s of Mylan, Watson and Teva batted this term around before Ms. Jaeger stepped in to ask if these were akin to 505(b)(2)s. The participants agreed that the concept behind 505(b)(2) for small molecules – make improvements to an approved drug product – should be allowed for biologics: a biobetter.

FDA head of the Office of Generic Drugs, Gary Buehler, stated that FDA has made the decision that generic biologicals would not be reviewed in OGD.

Though GPhA’s Jaeger indicates that 42 brand and generic companies are engaged in biologic research, there are truly only a handful of generic companies that can afford the 100’s of millions of dollars needed to develop a generic biological and take the risk that it will be approved. The vast number of generic companies in GPhA won’t be part of this market. Moreover, there are only about 28 approved biologics today and many will be obsolete or superseded by the time legislation is enacted and regulations approved. What will the generic industry look like in 5-10 years. Stay tuned to a future posting on this subject.

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